Events

Retiro De Equipo (Recall) de GE Healthcare Revolution EVO & Optima CT Systems CT660, CT670, CT680, CT540

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por GE Healthcare Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2018-RN-00499-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-05-16
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00499-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Ge healthcare has identified that some ct systems may have a damaged cable that can expose 120vac to service engineers working inside the gantry. this issue does not affect patients or operators external to the equipment.When the gantry front cover is removed to allow servicing of components inside the gantry, cover dollies are used to manipulate the cover. during the removal or reattachment of the front cover, a bracket can contact an internal power supply cable and damage that cable’s insulation. this can expose the conductor of a 120vac power supply cable and electrify the cover dolly, thereby introducing the risk of an electrical shock hazard to the service personnel.
  • Acción
    GE Healthcare is advising they will be in contact with affected users to arrange for the correction to be implemented. In the interim, the system may continue to be used as this issue does not impact patients or CT operators. Users should ensure service technicians are aware of the issue and to wear protective gloves when using the cover dollies. GE Healthcare have updated the service manual to prevent recurrence of this issue in the event of a replacement of the cable in the future. Users should follow the instructions outlined on the Customer Letter to download the latest Service Manual.

Device

GE Healthcare Revolution EVO & Optima CT Systems CT660, CT670, CT680, CT540
  • Modelo / Serial
    GE Healthcare Revolution EVO & Optima CT SystemsCT660, CT670, CT680, CT540Revolution EVO Model Numbers: 5454001-61, 5454001-160, 5454001-60 and 5454001-260 Optima CT660Model Numbers: 5454001, 5454001-41, -100, -220, -200, -40, -22, -140, -240, -122, -222Optima CT670/680 Model Numbers: 5454001-230, 5454001-330 Optima CT540Model Numbers: 5432539, 5432539-2, 5432539-3, 5432539-5 and 6447929ARTG Number: 116979
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd